Mon - Fri: 9:00 am EST - 06:00 pm EST
Call Us: (678) 385-6106
(Mon - Fri)
Mail us for help:
info@eemedicals.com
Enquiry Form:
Share Your Project
Home
About Us
Quality & Compliance
HEALTHCARE
Reliability
Six Sigma - Healthcare
QUALITY ASSURANCE
Medical Devices
Audits
Reliability
Quality Management System Regulation (QMSR)
Quality Management System Implementation
ISO
ISO 13485 Quality System Registration
ISO 14971 Device Risk Management
ISO 9001 Quality Management System
Free ISO 13485:2016 Gap Analysis Tool
Free ISO 9001:2015 Gap Analysis Tool
Regulatory Operations
Mark Approval / Licensing / Compliance
CCC Mark Approval
CE Mark Approval
EU MDR/IVDR Technical Documentation
Post-market Compliance
FDA 483 Warning Letter/Recalls and Remediation
Canada License Applications
Other Countries
Medical Device and Diagnostics
Investigational Device Exemption (IDE)
Premarket Notification 510(k), DeNovo, PMA
Establishment Registration
US Agent for Foreign Establishments
Drugs / Biologics / Pharmacovigilance
Investigational New Drug (IND) Application
New Drug Application(NDA)
Abbreviated New Drug Application (ANDA)
Biologics License Application (BLA)
Drug Master File (DMF) Submissions
Chemistry, Manufacturing, and Control (CMC)
AI-Enabled Regulatory
AI SaMD Regulatory Pathway Strategy
AI FDA Readiness & Deficiency Risk Audit
Predetermined Change Control Plan (PCCP) Authoring
AI Design Controls & QMSR Integration
FDA Interaction & Defense Support
Media
Software
Call Us: (678) 385-6106
(Mon - Fri)
Mail us for help:
info@eemedicals.com
Enquiry Form:
Share Your Project
Book a Free Microconsulting Appointment. Prepare all your questions.
February 2026
Mon
Tue
Wed
Thu
Fri
26
27
28
29
30
2
3
4
5
6
9
10
11
12
13
16
17
18
19
20
23
24
25
26
27
